Z-0715-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- December 29, 2021
- Termination Date
- December 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74
Product Description
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Reason for Recall
Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
UDI: 07613252084334; Lot Number: 3R7YHD